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Completed

NCT Number: NCT01472172

Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique

The purpose of this study is to determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. The secondary aim is to evaluate safety with focus on bleeding intensity.

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Key information

Conditions

Pleural Effusion Pleural Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University Clinic Golnik

Golnik, 4204, Slovenia

About this study

The primary aim of this study is to determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. We will assess size, morphological features, immunohistochemistry and diagnostic yield as measures of the quality of the samples. The secondary aim is to evaluate safety with focus on bleeding intensity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 or more years old
  • Unilateral pleural effusion of unknown origin
  • Pleural irregularities suspicious for pleural malignancy
  • Referral for thoracoscopy after less invasive means of diagnosis had failed

Exclusion criteria

  • Uncontrolled bleeding tendency
  • Unstable cardiovascular status
  • Severe heart failure
  • ECOG performance status 4
  • Persistent hypoxemia after evacuation of pleural fluid
  • Pleural symphisis, fibrothorax

Treatment and study plan

Cryobiopsy (Autoclavable cryoprobe 20416-032)

Device

The tip of the cryoprobe will be attached to suspicious part of parietal pleura and activated by footswitch for 3 seconds. The frozen tissue is going to be extracted by gently pulling of the probe. The probe with the attached biopsy sample is going to be removed together with the thoracoscope through trocar. The biopsy sample will be released from the probe by thawing in the saline.

Other names: Autoclavable cryoprobe 20416-032 (ERBE, Germany)

Primary outcomes

  1. Number / percent of patients with useful pleural biopsy sample, obtained by cryoprobe

    Time frame: 12 months

    To determine, wheather cryobiopsy specimen can be obtained in each patient

  2. Size of biopsy samples

    Time frame: 12 months

    Size of the biopsy specimens in mm2

  3. Quality of the sample

    Time frame: 12 months

    Interpretability of biopsy specimens in histopathology terms: 1. easily interpretable (enough tissue with all elements required for diagnosis) 2. interpretable with some difficulty (less tissue or diagnostic elements - diagnosis less reliable) 3. interpretable with great difficulty (little tissue or scarce diagnostic elements - low reliability of diagnosis) 4. non-interpretable (diagnosis not possible)

    Assessment of biopsy-related artifacts by describing the amount of unaltered tissue in quartiles

Secondary outcomes

  1. Bleeding

    Time frame: 1 month

    Number of patients with a certain degree of bleeding from biopsy site, described as:

    1 = slight, self-limited, 2 = moderate, requiring electrocautery intervention, 3 = severe, requiring interruption of the procedure, chest tube drainage and intravenous fluid resusucitation.

Sponsors and collaborators

Lead sponsor

The University Clinic of Pulmonary and Allergic Diseases Golnik

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 16, 2011
Registry last updated
Dec 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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